Trial Outcomes & Findings for Patient Factors Associated With Fragmentation of Copper Intrauterine Device (IUD) Requiring Hysteroscopic Removal (NCT NCT07351084)
NCT ID: NCT07351084
Last Updated: 2026-06-30
Results Overview
Identify patient risk factors for Cooper IDU fragmentation upon removal requiring a hysteroscopy by completing a retrospective chart review.
Recruitment status
COMPLETED
Target enrollment
44 participants
Primary outcome timeframe
January 2004- December 2024
Results posted on
2026-06-30
Participant Flow
Participant milestones
| Measure |
Hysteroscopy
Necessitated a hysteroscopic procedure.
Hysteroscopy: Retrospective chart review for those patients who had a hysteroscopy after IUD removal.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Factors Associated With Fragmentation of Copper Intrauterine Device (IUD) Requiring Hysteroscopic Removal
Baseline characteristics by cohort
| Measure |
Hysteroscopy
n=44 Participants
Necessitated a hysteroscopic procedure.
Hysteroscopy: Retrospective chart review for those patients who had a hysteroscopy after IUD removal.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Age, Customized
|
39.1 years
STANDARD_DEVIATION 8.1 • n=20 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=20 Participants
|
|
BMI
|
29.3 kg/m^2
STANDARD_DEVIATION 5.0 • n=20 Participants
|
|
Uterine abnormality
|
15 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: January 2004- December 2024Identify patient risk factors for Cooper IDU fragmentation upon removal requiring a hysteroscopy by completing a retrospective chart review.
Outcome measures
| Measure |
Hysteroscopy
n=44 Participants
Necessitated a hysteroscopic procedure.
Hysteroscopy: Retrospective chart review for those patients who had a hysteroscopy after IUD removal.
|
|---|---|
|
Number of Patients Who Underwent a Hysteroscopy Procedure Resulting From Intrauterine Device (IUD) Fragmentation Upon Removal
|
14 Participants
|
Adverse Events
Hysteroscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Annabel Mancillas, MD MPH FACOG
The University of Kansas Medical Center
Phone: 913-588-6200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place